Gene patents: it’s the sequence, stupid

Should your genome be balkanized into small fiefdoms of intellectual property? The briefs and court decisions in the Myriad BRCA patent case make for fascinating reading, because of the great effort expended by defenders of gene patents to deny that it’s the DNA sequence information that matters.

The historian of science Daniel Kevles has a lively review of this issue in the NY Review of Books. He gives us a clear example of how this denial of sequence value works:

The principal in the court majority was Judge Alan Lourie, who had been an organic chemist before turning to the law. He insisted that in patent law, unlike in biology, BRCA DNA was not information but was solely a chemical compound. Having been chemically modified at its ends upon extraction from its neighboring DNA, it differed sufficiently from the native version to be patent-eligible. He dismissed the Mayo ruling as irrelevant to the case, embracing arguments made by Myriad’s lawyers that the justices’ ruling in that case concerned a biomedical process while the Myriad case concerned DNA, a composition of matter.

To any working molecular biologist, this is ridiculous. DNA has no value solely as a chemical compound outside of the cell (unless you’re doing DNA origami). For this same reason, DNA is not analogous to a mineral extracted from the ground, or a kidney harvested from a body (to cite some other examples people have used). The isolated substance itself is irrelevant. It’s the sequence information that matters: the reason we isolate DNA as a chemical compound is to obtain its sequence. And sequence alone is not patentable.

But recognizing this would disrupt too many business interests:

The Court of Appeals’s several opinions made explicit that the case pitted the property rights of innovators and investors in gene-based biotechnology against the rights of free access to and use of human DNA by researchers, physicians, and patients. In effect, the absolute control inherent in DNA patents protects—and thus privileges—this sector of the biomedical complex against all others who have reasons to make use of human DNA. The instrument of the privilege is the current strict interpretation of patent law that is guided beyond legal logic by concerns for incentives to innovation and investment…

On September 25, 2012, the plaintiffs asked the Supreme Court to review the Court of Appeals’s August decision and on November 30 the Court accepted the case, confining its review solely to the fundamental question of whether genes are patentable.13 Its decision will determine whether the narrow or expansive interpretation of the law will apply to human DNA. In effect, to borrow from Madison’s assurance that patent monopolies posed no danger in the American democracy, it will declare whether the rights of the many—scientists, physicians, and patients—will be given standing in what has long been the province of the biotechnological few.

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Author: Mike White

Genomes, Books, and Science Fiction

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